Epadol Neo 1000 mg capsule number 60

Author Ольга Кияница

2017-05-11

Amount in a package 60
Product form Capsules
Manufacturer Kiev vitamin plant PAT (Ukraine, Kiev)
Registration certificate UA/12187/01/01
The main medicament Epadol
morion code 171152

Epadol Neo (Epadol Neo) user manual

Composition of the medicinal product:

active substance:
1 capsule contains ethyl omega-3 esters of 1000 mg,
which include:
eicosapentaenoic acid 300 mg;
docosahexaenoic acid 200 mg;
other fatty acids 498 mg;
d-α-tocopherol (Vitamin E) 2 mg;

excipients: gelatin capsule gelatine composition (gelatin, glycerin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216)).

Dosage form.

Capsules are soft.

Soft gelatin capsules from light yellow to dark yellow color, oval in shape, with a seam. The contents of the capsule are an oily liquid from light yellow to dark yellow with a specific odor.

Pharmacotherapeutic group.

Other lipid-lowering drugs. Omega-3-triglycerides, as well as other esters and acids. The code of automatic telephone exchange С10А Х06.

Omega-3 polyunsaturated fatty acids - eicosapentaenoic acid - (EPA) and docosahexaenoic acid (DHA) - refer to essential fatty acids.

The drug actively affects blood plasma lipids, reducing the level of triglycerides, low and very low density lipoproteins (VLDL). The drug affects hemostasis and reduces the risk of thrombus formation due to the effect on platelet aggregation capacity; moderately reduces blood pressure.

Normalization of the lipid spectrum of blood is also due to a decrease in the synthesis of triglycerides in the liver, since EPA and DHA inhibit the esterification of other fatty acids, as well as by reducing the amount of free fatty acids (the amounts of peroxisome β-oxidation of fatty acids increase) that participate in the synthesis of triglycerides . Reducing the synthesis of triglycerides leads to a decrease in the level of VLDL.

Alpha-tocopherol is an antioxidant that prevents the oxidation of polyunsaturated fatty acids.

Indications for use.

  • For primary prevention of atherosclerosis and cardiovascular diseases;
  • in the complex therapy of atherosclerosis, ischemic heart disease, arterial hypertension;
  • in secondary prevention of myocardial infarction in addition to standard treatment methods (eg, statins, antiplatelet agents, β-adrenoreceptor blockers, ACE inhibitors);
  • with hypertriglyceridemia in addition to diet therapy, if the latter is not effective enough.

Contraindications.

Increased individual sensitivity to any of the components of the drug. Exacerbation of chronic cholecystitis and chronic pancreatitis, exacerbation of diseases of the hepatobiliary system, cholelithiasis, pathological conditions accompanied by hemorrhagic syndrome.

Appropriate safety measures when used.

In case of a moderate increase in bleeding time (when using the drug in high doses, that is, 4 capsules per day), it is necessary to monitor the condition of patients receiving anticoagulant therapy and, if necessary, adjust the dose of anticoagulant accordingly. It is necessary to consider the possibility of increasing bleeding time in patients with an increased risk of hemorrhages (due to severe trauma, surgical intervention or other causes).

Do not prescribe a drug to treat exogenous hypertriglyceridemia (type I hyperchylomicronemia).

Patients with hepatic insufficiency (especially when taking the drug in high doses) need regular monitoring of liver function (ALT and ASAT).

The likelihood of developing side effects decreases with the use of the drug during meals.

Special caveats.

Use during pregnancy or lactation.

The use of the drug during pregnancy is only possible according to the doctor's prescription taking into account the risk / benefit ratio. During breastfeeding, the medication can be used after consultation with the doctor.

The ability to influence the reaction rate when driving or working with other machinery.

Does not affect.

Children.

Due to the lack of data on efficacy and safety, the drug is not administered to children under 12 years of age.

Method of administration and dose.

The drug is taken with food. For the purpose of prevention, adults and children over 12 years of age are prescribed 1 capsule per day. According to individual indications, the dose of the drug can be increased to 2 capsules per day.

In the complex therapy of cardiovascular diseases - 2 capsules per day.

In hypertriglyceridemia, the initial dose is 2 capsules per day (in 1 or 2 doses). In case of insufficient effect, the dose of the drug is increased to 4 capsules per day. Treatment should be continued until the necessary therapeutic effect is achieved.

Overdose.

In case of an overdose, allergic reactions similar to those observed with a side effect can be observed. Treatment: symptomatic therapy.

Side effects.

On the part of the immune system: hypersensitivity reactions.

From the side of metabolism and nutrition: hyperglycemia.

From the nervous system: dizziness, dysgeusia, headache.

Vascular disorders: arterial hypotension.

From the blood and lymphatic systems: hemorrhagic diathesis.

From the respiratory system, chest and mediastinum: dry nasal mucosa.

Gastrointestinal disorders: dyspeptic disorders, nausea, abdominal pain, gastrointestinal disorders (gastroesophageal reflux, eructation, vomiting, flatulence, diarrhea, constipation), gastritis, gastroenteritis, bleeding from the lower parts of the digestive tract.

From the hepatobiliary system: a violation of the liver.

From the skin and subcutaneous tissues: skin rash, itching, redness of the skin, urticaria, acne.

Laboratory indicators: an increase in the number of leukocytes, the level of lactate dehydrogenase in the blood, increased activity of transaminases.

Interaction with other drugs and other types of interactions.

It is not recommended to appoint together with fibrates due to lack of clinical experience. The appointment of Epadol Neo concomitantly with warfarin does not lead to hemorrhagic complications, however, in case of combined use of these drugs or discontinuation of treatment, Epadol Neo should monitor prothrombin time.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Packaging.

5 capsules per blister; 6 or 12 blisters per pack.

Category of vacation.

Without recipe.


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